noxafil

Generic: posaconazole

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name noxafil
Generic Name posaconazole
Labeler merck sharp & dohme llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

posaconazole 100 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0085-4324
Product ID 0085-4324_559c06b5-cdc2-4279-9561-a4aeec0a33aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205053
Listing Expiration 2027-12-31
Marketing Start 2013-11-25

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00854324
Hyphenated Format 0085-4324

Supplemental Identifiers

RxCUI
665019 665022 1482908 1482912 1492043 1492047 2558603 2558607
UPC
0300854324025
UNII
6TK1G07BHZ
NUI
N0000175487 M0002083

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name noxafil (source: ndc)
Generic Name posaconazole (source: ndc)
Application Number NDA205053 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET, COATED in 1 BOTTLE (0085-4324-02)
source: ndc

Packages (1)

0085-4324-02 60 TABLET, COATED in 1 BOTTLE (0085-4324-02)

Ingredients (1)

posaconazole (100 mg/1)

Linked Drug Pages (1)

NOXAFIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "559c06b5-cdc2-4279-9561-a4aeec0a33aa", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0300854324025"], "unii": ["6TK1G07BHZ"], "rxcui": ["665019", "665022", "1482908", "1482912", "1492043", "1492047", "2558603", "2558607"], "spl_set_id": ["b073b082-7b57-4423-8c06-4fd4263d6f84"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (0085-4324-02)", "package_ndc": "0085-4324-02", "marketing_start_date": "20131125"}], "brand_name": "NOXAFIL", "product_id": "0085-4324_559c06b5-cdc2-4279-9561-a4aeec0a33aa", "dosage_form": "TABLET, COATED", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0085-4324", "generic_name": "posaconazole", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NOXAFIL", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "100 mg/1"}], "application_number": "NDA205053", "marketing_category": "NDA", "marketing_start_date": "20131125", "listing_expiration_date": "20271231"}